efficacy of mr-hifu ablation of breast cancer

Conditions: Breast Cancer

Summary: this study evaluates the efficacy of mr-hifu ablation of breast cancer. ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo mr-hifu ablation, followed by mri and surgical resection to evaluate treatment effect. the main purpose of the study is to demonstrate the feasibility of total tumor ablation with mr-hifu. the secondary objective is safety assessment.


Eligibility criteria:
inclusion criteria: * women, aged 18 years and older. * able to give informed consent herself. * world health organization (who) performance score ≤ 2. * biopsy proven ct1-2 n0-2 mx invasive breast cancer with a size of ≤ 3.0 cm. * histological type of tumor: invasive ductal carcinoma (idc), not otherwise specified (nos) or no special type (nst). * the target breast fits in the cup of the dedicated mr-hifu breast system. * patient weight is limited to ≤ 90 kg, because of restrictions to the hifu table top. additional inclusion criteria based on dce-mri findings: * the distance of the tumor, including a 5 mm margin around the tumor, from the skin, nipple and pectoral wall is at least 1.0 cm measured on mri. * the tumor is located within the reach of the hifu beam produced by the transducers in the hifu breast system. exclusion criteria: * prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast. * contraindications to mr imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with mr bore). * contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (gfr \< 30 ml/min/1,73m2). * contra-indications for procedural sedation analgesia with propofol and esketamine or propofol and remifentanil. * extensive intraductal components in the lesion determined by biopsy. * scar tissue or surgical clips in the hifu beam path. * inability to lie in prone position. * pregnancy or lactation. * communication barrier with patient. the following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the bloom and richardson (b\&r) grading on the tumor biopsy is considered to high: * n0, her2neu negative, \<35 years, ≤1cm (t1a/b) with b\&r grade 1 or 2 on biopsy. * n0 her2neu negative, er/pr negative (triple negative), 35-70yr, 1.1-2cm (t1c) with b\&r grade 1 or 2 on biopsy. * n0, her2neu negative, er/pr positive \> 50%, ductal carcinoma, 60-70yr, 1.1-2cm (t1c), with b\&r grade 3 on biopsy and if the mammaprint is not reimbursed by health insurance also for grade 1 on biopsy. * n0, her2neu negative, er/pr positive, ductal carcinoma, 35-60yr, 1.1-2cm (t1c) with b\&r grade 1 on biopsy. * n0, her2neu negative, er/pr positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (t1c) with b\&r grade 1. the following group of patients will be excluded based on the results of the mammaprint: • only if the mammaprint is reimbursed by health insurance: n0, her2neu negative, er/pr positive, \> 50% ductal carcinoma, 60-70yr, 1.1-2cm (t1c), with b\&r grade 1 and mammaprint high risk.

Keywords: breast cancer mr-hifu ablation non-invasive treatment